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Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.
A study to evaluate the safety and effect of treatment with experimental antiviral drugs alone or in combination with ribavirin in treatment-naïve participants with genotype 1b hepatitis C infection. The study will test the safety and anti-viral activity of two regimens administered for a duration of 12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 12 weeks of Faldaprevir plus TD-6450 plus Ribavirin |
|
| Cohort 2 | Experimental | 12 weeks of Faldaprevir plus TD-6450 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faldaprevir | Drug |
|
| |
| TD-6450 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals with and without ribavirin in Genotype 1b Hepatitis C infected adults | Post Treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 with and without ribavirin) | Post Treatment Weeks 2 to 8 | |
| Safety as determined by the incidence of serious adverse events, Grade 3 or 4 adverse events and laboratory abnormalities, and discontinuations due to adverse events |
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Inclusion Criteria:
Chronic genotype 1b hepatitis C infection and HCV RNA ≥ 10^4 IU/mL at screening
Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening
Absence of cirrhosis as defined by one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ed Gane, MD | Auckland Clinical Studies Ltd | Principal Investigator |
| Tarek Hassanein, MD | Southern California Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Research Center | Coronado | California | 92118 | United States | ||
| Bach and Godofsky Infectious Diseases |
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| Drug |
|
| Ribavirin | Drug |
|
|
| Randomization through End of Study, up to 24 weeks |
| Bradenton |
| Florida |
| 34209 |
| United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Auckland Clinical Studies | Auckland | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Waikato Hospital | Waikato | New Zealand |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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